OsteoarthritisPASNewNCT00722007
Cormet Post-PMA Study: New Enrollment
A study testing Cormet Hip Resurfacing in people with Osteoarthritis and Avascular Necrosis, run by Corin at 6 sites in United States.
Trial summary
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Cormet Hip Resurfacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Apr 2008to 12 May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patient who meets eligibility criteria consistent with product labeling
- skeletally mature
- mentally capable of completing follow-up forms
- Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
- Has been deemed a candidate for hip replacement by diagnosis of the investigator
- consented to participate in the clinical study
Who cannot join
- Patient with active or suspected infection in or around the hip joint;
- Patient with bone stock inadequate to support the device
- Patient with severe osteopenia
- Patient with a family history of severe osteoporosis or severe osteopenia;
- Patient with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade)
- Patient with multiple cysts of the femoral head (>1cm)
Show all 13Show fewer
- In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
- Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
- Female of child-bearing age due to unknown effects on the fetus of metal ion release.
- Patient with known moderate or severe renal insufficiency;
- Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids;
- Patient who is severely overweight;
- Patient with known or suspected metal sensitivity (e.g., jewelry).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Memorial Bone and Joint Clinic
Houston, Texas, 77043
Lattimore Orthopaedics P.C.
Rochester, New York, 14620
Willamette Orthopedic Group LLC
Salem, Oregon, 97301
Florida Orthopaedic Institute
Tampa, Florida, 33637
George Washington University
Washington D.C., District of Columbia, 20006
About this study
Official title: Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Read the detailed description
This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Being tested
- Cormet Hip Resurfacing
- Keywords
- hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cormet Hip ResurfacingDevice
Also called Corin Cormet
Cormet Hip Resurfacing implant
| Study group | Role | What they receive |
|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | Experimental | hip resurfacing Receives: Device: Cormet Hip Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
Composite Clinical Success (CCS) is based upon the following:
There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points.
Measured: Month 24+
Secondary outcomes (4)
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
All unilateral and bilateral implants have been assessed using the following grading:
Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=<39); Moderate Dysfunction (20=<29); Severe Dysfunction (10=<19); Disabled (0=<9)
Measured: Month 24+
Survival Rate Using Kaplan-Meier Survival Curves
Kaplan-Meier survival curves were completed for all implants (unilateral \& bilateral) for Month 24
Measured: Month 24+
Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
Measured: Month 24+
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
The following was assessed:
Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration > 4mm; Medial/Lateral Migration > 4mm; Varus/Valgus Tilt > 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component > 4mm and Stem tilting > 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis
Measured: Month 24+
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study start24 Apr 2008
- Primary completion11 Apr 2014
- Study completion12 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722007
- Sponsor's protocol ID
- Cormet (P050016) New Enroll
- Acronym
- PASNew
- Status last verified
- May 2019
- First submitted
- 23 Jul 2008
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
- ClinicalTrials.gov ID
- NCT00722007
- Acronym / sponsor ID
- PASNew / Cormet (P050016) New Enroll
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Keywords
- hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2008 (actual)
- Primary completion
- 11 Apr 2014 (actual)
- Study completion
- 12 May 2014 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Detailed description
This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | Experimental | Device: Cormet Hip Resurfacinghip resurfacing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient who meets eligibility criteria consistent with product labeling
- skeletally mature
- mentally capable of completing follow-up forms
- Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
- Has been deemed a candidate for hip replacement by diagnosis of the investigator
Key exclusion criteria (13 listed)
- Patient with active or suspected infection in or around the hip joint;
- Patient with bone stock inadequate to support the device
- Patient with severe osteopenia
- Patient with a family history of severe osteoporosis or severe osteopenia;
- Patient with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cormet Hip ResurfacingAlso: Corin CormetCormet Hip Resurfacing implant | Device | Cormet Hip Resurfacing Post-PMA Group |
Primary outcome
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
Time frame: Month 24+
Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points.
4 secondary outcomes
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Time frame: Month 24+
Survival Rate Using Kaplan-Meier Survival Curves
Time frame: Month 24+
Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
Time frame: Month 24+
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Time frame: Month 24+
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cormet Hip Resurfacing in people with Osteoarthritis and Avascular Necrosis, run by Corin at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 (time frame: Month 24+). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.